FDA Grants Priority Review to Bristol Myers Squibb’s Breyanzi for Relapsed Marginal Zone Lymphoma; PDUFA Date December 5, 2025

Bristol Myers Squibb has received priority review from the U.S. Food and Drug Administration for its application of Breyanzi (lisocabtagene maraleucel) to treat relapsed or refractory marginal zone lymphoma, marking the fifth cancer type for which the therapy is being considered. The Prescription Drug User Fee Act (PDUFA) date for this review is December 5, 2025. Meanwhile, CASI Pharmaceuticals announced FDA clearance of its investigational new drug (IND) application for CID-103 targeting renal allograft antibody-mediated rejection. In related developments, the ALPHA3 trial investigating Cema-Cel in large B-cell lymphoma (LBCL) is proceeding with a fludarabine and cyclophosphamide lymphodepletion regimen. Allogene Therapeutics confirmed the selection of this standard lymphodepletion protocol for the ALPHA3 trial, discontinuing the previously used enhanced regimen. Additionally, the European Medicines Agency granted PRIME designation to BeiGene’s BGB-16673 for patients with previously treated Waldenström macroglobulinemia.